My Knee Tibial Cutting Blocks MIS

GUDID 07630030853395

MRI Left Lateral #6

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630030853395
• NIH Device Record Key: 9fbe7cd1-0ae4-4865-af41-3b80b27cc1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Knee Tibial Cutting Blocks MIS
• Version Model Number: 4.2286
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030853395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093806

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

[07630030853395]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-11-18

On-Brand Devices [My Knee Tibial Cutting Blocks MIS]

• 07630030853517: MRI Right Lateral #6
• 07630030853494: MRI Right Lateral #5
• 07630030853470: MRI Right Lateral #4
• 07630030853456: MRI Right Lateral #3
• 07630030853432: MRI Right Lateral #2
• 07630030853418: MRI Right Lateral #1
• 07630030853395: MRI Left Lateral #6
• 07630030853371: MRI Left Lateral #5
• 07630030853357: MRI Left Lateral #4
• 07630030853333: MRI Left Lateral #3
• 07630030853319: MRI Left Lateral #2
• 07630030853296: MRI Left Lateral #1
• 07630030853005: MRI Right Medial #6 Sterile
• 07630030852992: MRI Right Medial #6
• 07630030852985: MRI Right Medial #5 Sterile
• 07630030852978: MRI Right Medial #5
• 07630030852961: MRI Right Medial #4 Sterile
• 07630030852954: MRI Right Medial #4
• 07630030852947: MRI Right Medial #3 Sterile
• 07630030852930: MRI Right Medial #3
• 07630030852923: MRI Right Medial #2 Sterile
• 07630030852916: MRI Right Medial #2
• 07630030852909: MRI Right Medial #1 Sterile
• 07630030852893: MRI Right Medial #1
• 07630030852886: MRI Left Medial #6 Sterile
• 07630030852879: MRI Left Medial #6
• 07630030852862: MRI Left Medial #5 Sterile
• 07630030852855: MRI Left Medial #5
• 07630030852848: MRI Left Medial #4 Sterile
• 07630030852831: MRI Left Medial #4
• 07630030852824: MRI Left Medial #3 Sterile
• 07630030852817: MRI Left Medial #3
• 07630030852800: MRI Left Medial #2 Sterile
• 07630030852794: MRI Left Medial #2
• 07630030852787: MRI Left Medial #1 Sterile
• 07630030852770: MRI Left Medial #1
• 07630030849916: CT Right Lateral #6
• 07630030849893: CT Right Lateral #5
• 07630030849879: CT Right Lateral #4
• 07630030849855: CT Right Lateral #3
• 07630030849831: CT Right Lateral #2
• 07630030849817: CT Right Lateral #1
• 07630030849794: CT Left Lateral #6
• 07630030849770: CT Left Lateral #5
• 07630030849756: CT Left Lateral #4
• 07630030849732: CT Left Lateral #3
• 07630030849718: CT Left Lateral #2
• 07630030849695: CT Left Lateral #1
• 07630030849404: CT Right Medial #6 Sterile
• 07630030849398: CT Right Medial #6